MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number	03P68-34
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for magnesium reagent lot number 70058ud00.Trending review determined no trends for discrepant patient results for the product.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.The sample was rerun with the same reagent lot and generated lower results.The quality control was performing within the expected ranges, which shows that the assay was performing as expected.Based on the investigation, no systemic issue or deficiency of the architect magnesium reagent lot number 70058ud00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely elevated magnesium result generated on the architect c16000 processing module on a patient.The following results were provided: sid (b)(6) = 3.21 / 0.86 mmol/l no impact to patient management was reported.

• Brand Name: ARCHITECT MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22121915
• Report Number: 3005094123-2025-00269
• Device Sequence Number: 17908128
• Product Code: JGJ
• UDI-Device Identifier: 00380740169862
• UDI-Public: (01)00380740169862(17)250822(10)70058UD00
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2025
• Device Catalogue Number: 03P68-34
• Device Lot Number: 70058UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Sex: Unknown